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Pain pill showdown: ultracet vs. voltaren for back inflammation

NCT ID NCT00766402

Symptom relief Sponsor: Johnson & Johnson Taiwan Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two pain medications—Ultracet (tramadol/acetaminophen) and Voltaren (diclofenac)—in people with ankylosing spondylitis who were already taking disease-modifying anti-rheumatic drugs (DMARDs). The goal was to see which one worked better for pain relief over 8 weeks. Only 8 people enrolled, and the study was terminated early, so the results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tramadol/acetaminophen (Ultracet) and diclofenac (Voltaren)
What this could lead to
If successful, this could show that adding a pain reliever like Ultracet helps people with ankylosing spondylitis manage pain better while continuing their regular anti-rheumatic drugs.
What could go wrong
This was a very small, early-terminated Phase 4 study with only 8 participants, so results are not reliable. Pain relief may not differ between the two drugs, and side effects like nausea or dizziness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

8 people

The number who actually took part.

Started

Sep 2008

Finished

Mar 2009

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of ankylosing spondylitis (AS), as defined by Modified New York Criteria for ankylosing spondylitis: a) Low-back pain of at least 3 months duration improved by exercise and not relieved by rest b) Limitation of lumbar spine in sagittal and frontal planes c) Chest expansion decreased relative to normal values for age and sex d) Bilateral sacroiliitis, grade 2-4 or Unilateral sacroiliitis, grade 3-4 (Stoke) * Participants are suffering from pain, with visual analogue scale (VAS) pain score greater than or equal to (\>=) 40 millimeter (mm) * Participants are receiving disease modifying anti-rheumatic drugs (DMARDs), which have reached to the stable dosage within 4 weeks prior to the randomization visit - Serum creatinine less than or equal to (\<=) 1.2 milligram per deciliter (mg/dL) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 times the laboratory's upper limit of normal * Exclusion Criteria: * Had an inadequate response to tramadol hydrochloride (HCl) therapy, or have discontinued tramadol HCl therapy due to adverse events * Have taken tramadol HCl within 4 weeks prior to the entry of the study * Have taken other medications for pain relief within 4 weeks prior to the entry of the study, except rescue medications * Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders * Women with pregnancy or breast-feeding

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain Spondylitis, ankylosing

Contacts and locations

Locations

  • Johnson & Johnson Taiwan Ltd.

    Taipei, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.